Tag: BrainQ

[BrainQ in PR Newswire] BrainQ announces encouraging study results for new therapy to reduce disability after stroke

JERUSALEM, March 11, 2021 /PRNewswire/ — BrainQ, the Israeli start-up with an AI-powered therapeutic platform, today revealed the encouraging results of their Randomized Controlled Trial (RCT) which supported a recently granted request for FDA Breakthrough Device Designation. The pilot trial data will be presented as part of the International Stroke Conference between March 17-19. Read more...

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[BrainQ in The Marker] חברת BrainQ מציגה שיפור של 77% בחולים שחוו שבץ מוחי

חברת BrainQ הישראלית פירסמה היום (ה’) את תוצאות הניסוי הקליני שנערך ב-25 מטופלים שחוו שבץ מוחי. תוצאות הניסוי, שיוצגו בכנס השבץ הבינלאומי שייערך ב-19-17 במארס, היו הבסיס להחלטת רשות המזון והתרופות האמריקאית (FDA) להעניק לחברה מעמד של מכשור רפואי פורץ דרך. Read more...

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[BrainQ in PR Newswire] BrainQ gets FDA Breakthrough status for its device for reducing disability following stroke

JERUSALEM, Feb. 11, 2021 /PRNewswire/ — BrainQ, the Israeli start-up with a therapeutic solution to reduce disability following stroke, announced today that the United States Food and Drug Administration (FDA) has designated its AI-powered technology as a Breakthrough Device. The designation, which was based on BrainQ’s latest randomized controlled clinical trial results for ischemic stroke patients, provides BrainQ with the opportunity to work closely with the FDA to expedite development plans and premarket clearance. Breakthrough status also gives BrainQ access to the new Medicare Coverage of Innovative Technology (MCIT) pathway, allowing for Medicare coverage to be provided concurrently with FDA market authorization. Read more...

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